GUEST COLUMNISTS

• The 10 Phases Of An Effective CAPA

  Corrective and preventive action (CAPA) issues continue to be one of the top Form 483 observational findings by the FDA. Many times, CAPAs fail due to the structure and flow of the process and not necessarily the efforts of those managing the CAPAs. A poor paper-based CAPA process will not improve with an electronic-based CAPA system.

• 3 Building Blocks Of Organizational Agility For Pharmaceutical Manufacturing

  Part 1 of this three-series looked at why agility is so important to pharmaceutical manufacturers and their contract manufacturing and development organizations (CDMOs) and is key to reaching the next productivity level of project management. Here in Part 2, we dig deeper into the details of the building blocks of an Agile approach and the methods that can be used to achieve it.

• Choosing A CDMO: If You Can’t Answer 'Yes' To These 3 Questions, Walk Away

  Choosing the right CDMO is the most important factor in the success of drug product and process development, particularly for small and virtual companies. To choose the right CDMO, you must look past the opening presentation, the facility walk-throughs, and even the compliance audit.

• The 4 Most Important Elements Of A Successful Sponsor-CDMO Relationship

  When a sponsor contracts with a manufacturing organization to execute a scope of work or series of tasks on its behalf, the sponsor takes on a level of oversight different from that within its own organization. This article highlight how four understated considerations can play an important role in a successful relationship between sponsor and CMO.

• Biosimilar Litigation Review: BPCIA Cases Settled Or Dismissed In 2019

  This is the second article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding Biosimilars Price Competition and Innovation Act district court litigation and reviewed ongoing BPCIA district court cases. In Part 2, we turn our attention to BPCIA district court cases that were settled in 2019.

• Recommendations For Managing Complexity In Biopharma Operations

  There's a tendency in biopharma operations to make things more complex than they need to be. More content in an SOP, additional signatures, new forms, and control loops don't necessarily equate to better.

• An Introduction To Agile Project Management For Pharmaceutical Outsourcing

  Modern sponsor-CDMO partnerships must be agile and flexible, bringing together professionals from multiple disciplines to find solutions that increase efficiency.

• Non-Hodgkin’s Lymphoma CAR T-Cell Therapy: Where Do We Go From Here?

  Following the success of Kite/Gilead’s Yescarta and Novartis’ Kymriah in treating relapsed or refractory diffuse large B-cell lymphoma, key players are pursuing therapies in earlier treatment settings and in mantle cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma.